FDA 510(k) Application Details - K120626

Device Classification Name	Azo Dye, Calcium   More FDA Info for this Device
510(K) Number	K120626
Device Name	Azo Dye, Calcium
Applicant	VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD 189-199 BROWNS RD NOBLE PARK 3174 AU Other 510(k) Applications for this Company
Contact	MELITA LAMBIRIS Other 510(k) Applications for this Contact
Regulation Number	862.1145   More FDA Info for this Regulation Number
Classification Product Code	CJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2012
Decision Date	08/22/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review